Psychological Options for Wellness and Recovery (POWeR) Trial for Veterans With Chronic Back/Neck Pain

University of Colorado Denver (CU Denver)

Status: Begins enrollment in 1 month

Conditions: Back Pain; Back Pain Lower Back Chronic; Chronic Pain; Neck Pain

Treatments: Behavioral: Pain reprocessing therapy (PRT); Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP); Other: Usual Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07137715

24-2398

HT9425-24-1-0915 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this clinical trial is to learn which treatment works better for veterans with chronic neck or back pain. This study is comparing three treatments: Pain Reprocessing Therapy (PRT), Cognitive Behavioral Therapy (CBT), and usual care (whatever a person is already doing to cope with their pain).

The main questions the study aims to answer are:

1. Which treatment works better for lowering pain: PRT, CBT, or usual care?
2. How do the effects of PRT compare with CBT and usual care in terms of pain relief and other factors such as emotional functioning, quality of life, anxiety, and pain medication use?

Participants will:

1. Be randomly assigned to receive either PRT, CBT, or usual care.
2. Complete questionnaires about their pain and health.
3. If in the PRT or CBT group, have nine weekly therapy sessions over video calls with a therapist.

Full description

The current leading psychotherapeutic treatment for chronic pain is cognitive behavioral therapy (CBT-CP), which has been found to be safe and modestly efficacious in the treatment of chronic back or neck pain (CBNP). The fundamental goal of CBT-CP is to encourage participants to adopt an active, problem-solving approach to managing the challenges associated with chronic pain. CBT-CP intervention follows a standard structure of 9 sessions with the following objectives: 1) reducing the negative impact of pain on daily life 2) improving physical and emotional functioning 3) increasing effective coping skills for managing pain 4) reducing pain intensity. Recent evidence shows CBT provides a 1-1.5 point reduction in pain intensity on an 11-point pain scale when compared to treatment as usual.

Using advances in neuroscience and psychology, investigators recently developed a novel psychological treatment called Pain Reprocessing Therapy (PRT). Using a combination of cognitive, exposure-based, and somatic psychotherapy techniques, PRT aims to promote patients' reconceptualization of pain as due to reversible, non-dangerous brain activity rather than peripheral pathology. Critically, PRT aims to reduce or eliminate pain, rather than merely increase functioning.

In the first trial of PRT (N = 151), 66% of patients randomized to PRT were pain-free or nearly pain-free at post-treatment, compared to fewer than 20% of those in the placebo and usual care control groups. PRT has several critical conceptual distinctions from CBT including different approaches to pain subtyping, a different understanding of chronic pain etiology, differing treatment goals (recovery vs. improved functioning), and a different focus on non-pain psychosocial threats. Given the conceptual differences and early existing promising efficacy data of PRT, a critical next step to achieve practical improvements in Veteran health is a comparative effectiveness trial of PRT vs. CBT in a Veteran Affairs (VA) clinic, utilizing VA clinicians, VA treatment infrastructure, and Veteran participants.

Aim 1 of this study is to test the comparative effectiveness of PRT to CBT and usual care on pain severity for veterans with CBNP at post-treatment and one year follow-up.

Aim 2 of this study is to test the comparative effectiveness of PRT to CBT and usual care on secondary patient-reported outcomes measuring core outcome domains, quality of life, and opioid medication use.

Aim 3 of this study is to identify key barriers and facilitators of PRT response in a Veteran population using qualitative methods in a subsample of participants (n = 40) and in clinicians learning PRT.

Enrollment: 360 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (18 and older)
• Be veterans
• Have a history of chronic back or neck pain defined as pain at least half the days of the last 6 months.
• Have moderate or greater pain, defined as pain intensity ≥4 in the past week

Exclusion criteria

Clinical presentation suggestive of back pain that is secondary or peripheral in nature, including self-reported leg pain that is worse than back pain (indicative of radiculopathy or sciatica), spine surgery within the past 6 months, fall, motor vehicle accident or other trauma related to back pain in the past 6 months, back pain due to an inflammatory disorder, infection, or malignant etiology as determined per medical provider review, known sensory abnormality in trunk or legs, recent large (>20 lbs) unexplained weight loss, difficulty controlling bowels (to screen out cauda equina syndrome), and self-reported diagnoses of specific inflammatory disorders (rheumatoid arthritis, polymyalgia rheumatica, scleroderma, Lupus, and polymyositis).

Additionally, patients who meet any of the following criteria are ineligible due to anticipated difficulties complying with study procedures:

• Moderate or severe cognitive impairment
• Unstable or severe untreated mental health condition, including active suicidal ideation
• Unstable or end-stage medical disease including active cancer
• Back surgery planned within the next 6 months
• Inability to communicate by telephone or video, including inability due to housing instability
• Current pain-related litigation outside the VA (service connection-related applications are not excluded)
• Having engaged in CBT or PRT for chronic pain in the past 6 months
• Participants may be excluded based on the discretion of PIs Ashar and Frank

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Pain reprocessing therapy (PRT)

Experimental group

Description:

PRT has 5 components: 1) education about the origin of pain in the brain, its reversibility, and the pain-fear cycle; 2) reinforcing education using personal biography; 3) "somatic tracking" of pain through mindfulness and reappraisal of pain sensations as non-dangerous; 4) lowering the level of personal threat that may trigger pain sensation; and 5) inducing positive affect in periods of pain. Patients will attend 1 assessment and education telehealth session with a physician followed by 8, 50-minute, therapist-led sessions. Pacing will be weekly for approximately 9 weeks. Treatment will be provided by experienced PRT clinicians. All PRT sessions will be remotely-delivered.

Treatment:

Behavioral: Pain reprocessing therapy (PRT)

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Active Comparator group

Description:

CBT-CP, considered the leading psychological treatment for chronic pain, is a structured, time-limited intervention that aims to teach patients how to better manage chronic pain and improve their quality of life. Participants will receive 9, 50-minute sessions of CBT-CP over 9 weeks. The VA CBT-CP protocol contains an initial orientation involving education and familiarization with the CBT-CP approach to chronic pain. The protocol then includes sessions that focus on topics such as exercise, relaxation, pleasant activities, cognitive coping, and sleep. All CBT-CP sessions will be remotely-delivered.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)

Usual Care

Active Comparator group

Description:

Participants will be asked to continue whatever they are already doing to care for their back pain. Length of the usual care condition will be 9 weeks, the expected completion time of the PRT and CBT arms.

Treatment:

Other: Usual Care